Three-year results document myopic ICL safety, efficacy

August 15, 2004

Eugene, OR-Three-year FDA clinical trial results establish the efficacy of the myopic Implantable Contact Lens (ICL, STAAR Surgical) for correcting –3 to –20 D of myopia and substantiate its overall safety in patients with moderate to high myopia, said I. Howard Fine, MD.

The study enrolled 526 eyes of patients who were 21 to 45 years old. All participants received Version 4 of the ICL, which is designed to fit into the sulcus and vault over the crystalline lens. Data from the 3-year visit were available for 363 eyes.

The results showed that ICL implantation surgery resulted in immediate and stable refractive correction accompanied by rapid return to good visual acuity that was sustained throughout the follow-up interval. Only five eyes (<1%) experienced a persistent loss of >2 lines of best spectacle-corrected visual acuity (BSCVA), the incidence of visually significant anterior subcapsular opacity was extremely low (0.4%), and only three eyes (0.6%) in the entire series underwent cataract extraction.

However, Dr. Fine observed that those outcomes must be interpreted against the background of the characteristics of the study population-notably the trial cohort included patients with preoperative BSCVA worse than 20/20 and those with up to 2.5 D of refractive cylinder. Furthermore, not all eyes were targeted for emmetropia.

"The results are much better when considering only eyes correctable to 20/20 or better preoperatively or those meeting that criterion and who were targeted for emmetropia. At 3 years, rates of UCVA of 20/20 or better in those two subgroups were 52% and 59%, respectively, with UCVA of 20/40 or better achieved at rates of 89% and 95%, respectively," he said.